Role of Functional Neurosurgery in Management of Spasticity

NCT05731648 | Unknown

• 1 other identifier: Neurosurgery and spasticity
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Spasticity can result from a variety of causes in neural axis from which most common are cerebral palsy, strokes, cerebral haemorrhage, multiple sclerosis , traumatic brain injury and spinal cord injury and underlying mechanism is broadly due to decrease inhibition of the spinal network. Clinical evaluation for spasticity involve series of clinical assessment , physical examination , and neurophysiological testing. quantitative evaluation of spasticity can be measured using modified Ashworth scale which is the most widely used clinical spasticity scale and can be used for various clinical conditions causing spasticity

Conditions

Functional Neurological Disorder

Outcome Measures

Primary Outcomes (2)

• Evaluate safety and efficacy of neurosurgical procedures

  Rate of complication ( infection , bleeding , Device Malware )

  6 month

• Evaluate Changes in Modified Ashworth scale

  * 0: No increase in muscle tone * 1: Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension * 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion * 2: A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved * 3: Considerable increase in muscle tone, passive movement difficult * 4: Affected part(s) rigid in flexion or extension

  6 month

Interventions

Intrathecal balofen pump DEVICE

Management of spasticity

Also known as: spinal cord stimulator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Spasticity

You may qualify if:

• Patients with spasticity refractory to medical treatment (most commonly administered oral medications for managing spasticity are diazepam, dantrolene sodium, and baclofen) and physiotherapy

You may not qualify if:

• Patients unfit for neurosurgical intervention

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Hinderer SR, Dixon K. Physiologic and clinical monitoring of spastic hypertonia. Phys Med Rehabil Clin N Am. 2001 Nov;12(4):733-46.

  PMID: 11723863 BACKGROUND

• Kheder A, Nair KP. Spasticity: pathophysiology, evaluation and management. Pract Neurol. 2012 Oct;12(5):289-98. doi: 10.1136/practneurol-2011-000155.

  PMID: 22976059 RESULT

MeSH Terms

Conditions

Conversion Disorder

Condition Hierarchy (Ancestors)

Somatoform Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 16, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: February 16, 2023

Record last verified: 2023-02